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    Xellia starts commercial production and distribution of premix bag products

    29 Nov 2023

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    Xellia Pharmaceuticals Cleveland, Ohio Manufacturing site is now operational.

    17 Aug 2021

    // BUSINESSWIRE

    Xellia Pharms Aps's Generic Micafungin Sodium Receives Approval In US

    02 Jun 2021

    // FDA

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    Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.

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    Xellia is a global leader in fermentation-based anti-infectives, supplying APIs and finished dosage forms for severe and life-threatening infections. As one of the last Western manufacturers of essential anti-infective APIs, we combine EU-based production with a proven record of uninterrupted supply. Backed by deep expertise and long-term commitment, we continuously invest in quality, compliance, and manufacturing excellence to ensure reliable access to critical medicines worldwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
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    #PharmaFlow by PHARMACOMPASS
    09 Apr 2026
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    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

    Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities.  North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent.  Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available)  Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.  
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    16 Jan 2025
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    BMS, Bayer, Takeda, Pfizer downsize to combat cost pressures, meet restructuring plans

    Over the last two years, there has been a significant surge in layoffs by pharmaceutical and biotech companies. The trend spilled over to 2024. Data compiled by PharmaCompass indicates that between January and early-September, around 150 companies had implemented layoffs. Bristol Myers Squibb (BMS) tops the list of companies that downsized, with a staggering 2,284 job cuts. Bayer stood second at 1,816 retrenchments, followed by Takeda Pharmaceuticals at 1,155. Johnson & Johnson’s spin-off Kenvue is slashing over 1,000 jobs this year, while Roche subsidiary Genentech is cutting 529 positions, and Novartis is going ahead with its multi-year restructuring, and cutting another 770 jobs. One of the primary drivers of layoffs has been the need for companies to streamline operations and reduce costs. Many firms have faced financial pressures due to reasons such as declining revenues, increased competition, and the high costs associated with drug development. The current wave of layoffs has encompassed geographies – from traditional pharma strongholds like New Jersey, biotech hubs in Massachusetts and California, to Europe (particularly Germany and Switzerland). This is not to suggest that job cuts are a norm. Certain segments have been experiencing substantial growth and job creation. This includes companies like Eli Lilly and Novo Nordisk that have experienced remarkable growth due to the efficacy of their glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that treats type 2 diabetes and obesity.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available) BMS cuts 2,284 jobs to meet cost targets, Bayer hands pink slips to 1,816 employees Several large drugmakers have announced job cuts this year in order to meet their cost cutting goals, or as part of their restructuring exercise. BMS’ revenue had declined from US$ 46.2 billion in 2022 to US$ 45 billion in 2023. The financial pressure has compelled it to cut 2,284 jobs so far in this year, a move that sent shockwaves through the industry. Overall, BMS hopes to save approximately US$ 1.5 billion in costs by 2025 through this “strategic productivity initiative”. In Europe, Swiss-based companies like Novartis and Roche have announced substantial job cuts, while Bayer is reducing its workforce globally.  Bayer is laying off 1,816 employees worldwide, including 150 in Basel, Switzerland. A majority of these are management roles as the German drugmaker seeks to target € 500 million (US$ 557 million) in cost savings in 2024 and € 2 billion (US$ 2.23 billion) in 2026. Japanese drugmaker Takeda plans to eliminate 1,155 positions, including 324 jobs in San Diego and 641 in Massachusetts. Takeda is also winding down production and R&D operations in Austria, resulting in 190 job losses. Starting next month, Genentech, a Roche subsidiary, will lay off 93 employees in San Francisco. Earlier this year, Genentech trimmed roughly 3 percent of its workforce across several departments, impacting 436 employees. Roche also laid off around 340 employees in its product development team. Novartis has been undergoing a significant restructuring exercise since 2022, when it announced 8,000 job cuts in its global workforce. This year, it announced an additional 770 job cuts in its product development organization, separate from the previous reductions. Once again, it was workforces in Switzerland (440 job cuts) and US (269 job cuts) that bore the brunt. Tylenol and Band-Aid maker Kenvue, which spun off from J&J last year, announced plans to cut 920 jobs, representing about 4 percent of its global workforce. Additionally, the company will lay off 51 employees in New Jersey and 84 in California. These layoffs are part of Kenvue’s efforts to adjust its cost structure and become more competitive.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Perrigo, Emergent Bio, Catalent, BioMarin trim workforces amid strategic shifts Several mid-size companies too are under tremendous cost pressures, with some of them feeling the need to reinvent themselves for the future. In February this year, Perrigo had embarked on ‘Project Energize’, a three-year initiative aimed at boosting organizational agility and achieving long-term success. As part of this project, Perrigo is cutting costs and laying off 6 percent of its staff, which translates into nearly 550 employees. CDMO-turned-biopharma Emergent BioSolutions plans to reduce its workforce by about 300 employees. The Maryland-based multinational is closing its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility in the state. Rare disease biotech BioMarin laid off 395 employees globally, about 12 percent of its workforce, as part of “organizational redesign efforts” to prioritize its new strategy with its hemophilia A gene therapy Roctavian and to preserve cash. Drug-delivery specialist Catalent has also been significantly impacted by restructuring efforts ever since it announced 1,100 layoffs in December. It had then attributed its fall in revenue to declining Covid-related sales, but had also noted that future GLP-1 manufacturing revenues could help stabilize its finances. True enough — it subsequently announced that it is in the process of being acquired by Novo Nordisk’s parent company for US$ 16.5 billion. However, Catalent reported reducing its headcount by an additional 300 in the fourth quarter of 2023.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Pfizer job cuts continue to trickle in; Lykos, Lyra downsize after pipeline setbacks Clinical trial failures and financial constraints have also played a significant role in this year’s wave of layoffs. At Pfizer, job cuts continued to trickle in, with some estimates putting the number at 1,500 employees in 2024. These include 285 at its vaccine R&D site in New York, and 52 in San Francisco. The Comirnaty maker also pulled the plug on a long-anticipated, near-complete Seagen drug manufacturing plant in Everett, Washington. About 120 employees at the site were let go.  It has been a tumultuous time for Lykos Therapeutics, following the US Food and Drug Administration’s rejection of its MDMA-assisted therapy for post-traumatic stress disorder. Lykos announced laying off 75 percent of its staff (i.e. 75 employees). Its founder, who had spent 38 years working on the therapy, left the company and so did its CEO. However, Lykos has not given up and has roped in a Janssen veteran as senior medical advisor to get the therapy past the finish line. Similarly, Lyra Therapeutics is laying off 75 percent of its workforce (i.e. 87 employees) following disappointing late-stage results for its implant to treat chronic rhino-sinusitis. The retrenchments include its chief technology officer.  View Our Interactive Dashboard on Biopharma Layoffs in 2024 as of Sept. 7 (Free Excel Available)  Our view Technology, regulatory and pricing pressures are shaping strategies of pharmaceutical companies. The drive to do more with less could accelerate the adoption of artificial intelligence, machine learning, and automation in drug discovery and development processes. The employment landscape is certainly evolving. We foresee significant changes in the skills required for pharmaceutical and biotech careers, with a growing emphasis on data science and computational biology.
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    #PharmaFlow by PHARMACOMPASS
    19 Sep 2024
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    Xellia starts commercial production and distribution of premix bag products
    Xellia starts commercial production and distribution of premix bag products

    29 Nov 2023

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    https://www.businesswire.com/news/home/20231129891959/en

    BUSINESSWIRE
    29 Nov 2023
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    Xellia Pharmaceuticals Cleveland, Ohio Manufacturing site is now operational.
    Xellia Pharmaceuticals Cleveland, Ohio Manufacturing site is now operational.

    17 Aug 2021

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    https://www.businesswire.com/news/home/20210817005498/en

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    17 Aug 2021
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    Xellia Pharms Aps's Generic Micafungin Sodium Receives Approval In US
    Xellia Pharms Aps's Generic Micafungin Sodium Receives Approval In US

    02 Jun 2021

    // FDA

    https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211713

    FDA
    02 Jun 2021
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    Xellia Pharmaceuticals becomes member of Medicines for Europe
    Xellia Pharmaceuticals becomes member of Medicines for Europe

    20 Jan 2021

    // PHARMAFILE

    http://www.pharmafile.com/news/569327/xellia-pharmaceuticals-becomes-member-medicines-europe

    PHARMAFILE
    20 Jan 2021
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    Xellia Launches New Doses of VANCO READYTM
    Xellia Launches New Doses of VANCO READYTM

    05 Oct 2020

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20201005005340/en

    BUSINESSWIRE
    05 Oct 2020
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    Xellia Pharmaceuticals Expands Approved Doses of VANCO READYTM
    Xellia Pharmaceuticals Expands Approved Doses of VANCO READYTM

    02 Sep 2020

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    https://www.businesswire.com/news/home/20200902005164/en/Xellia-Pharmaceuticals-Expands-Approved-Doses-VANCO-READYTM#:~:text=COPENHAGEN%2C%20Denmark%2D%2D(BUSINESS%20WIRE,RTU)%20Vancomycin%20injection%20premix%20bags.

    BUSINESSWIRE
    02 Sep 2020
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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-02-13

    Pay. Date : 2012-11-19

    DMF Number : 13682

    Submission : 1998-09-01

    Status : Active

    Type : II

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    02

    Bacitracin Sterile Usp

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-12-26

    Pay. Date : 2012-10-31

    DMF Number : 13341

    Submission : 1998-09-01

    Status : Active

    Type : II

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    03

    Bacitracin Usp Non-sterile

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-17

    Pay. Date : 2012-10-31

    DMF Number : 13607

    Submission : 1998-09-01

    Status : Active

    Type : II

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    04

    Bacitracin Zinc Usp Non-sterile

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 13608

    Submission : 1998-09-01

    Status : Active

    Type : II

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    05

    Bacitracin Zinc, Sterile

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-08-07

    Pay. Date : 2014-06-13

    DMF Number : 28355

    Submission : 2014-06-20

    Status : Active

    Type : II

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    06

    Colistimethate Sodium Usp

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 13363

    Submission : 1998-09-01

    Status : Active

    Type : II

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    07

    Dalbavancin Hydrochloride

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2024-04-23

    Pay. Date : 2024-01-29

    DMF Number : 39378

    Submission : 2024-03-27

    Status : Active

    Type : II

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    08

    Daptomycin Non-sterile

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-10-19

    Pay. Date : 2013-06-25

    DMF Number : 27179

    Submission : 2013-07-16

    Status : Active

    Type : II

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    09

    Gramicidin, Usp

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-12-27

    Pay. Date : 2012-11-15

    DMF Number : 17538

    Submission : 2004-07-12

    Status : Active

    Type : II

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    10

    Polymyxin B Sulfate

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    Xellia Pharmaceuticals

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-08

    Pay. Date : 2012-10-31

    DMF Number : 14187

    Submission : 1999-06-10

    Status : Active

    Type : II

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    Drugs in Development

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    Virtual BoothXellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.

    Xellia Pharmaceuticals expands approved doses of VANCO READY™ (Ready-to-use Premixed Vancomycin bags)

    Details:

    Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.


    Lead Product(s): Vancomycin HCl

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Vanco Ready

    Study Phase: Approved FDFProduct Type: Antibiotic

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 02, 2020

    Company Banner

    01

    Xellia Pharmaceuticals

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    Lead Product(s) : Vancomycin HCl

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Xellia Pharmaceuticals expands approved doses of VANCO READY™ (Ready-to-use Premixed Vancomycin ...

    Details : Xellia Pharmaceuticals has received approval for 3 additional dosages of VANCO READY™, expanding its range of room-temperature-stable, ready-to-use (RTU) Vancomycin injection premix bags.

    Product Name : Vanco Ready

    Product Type : Antibiotic

    Upfront Cash : Inapplicable

    September 02, 2020

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    Eton Pharmaceuticals and Xellia Pharmaceuticals Announce Biorphen® (phenylephrine HCl) Co-Promotion Agreement

    Details:

    Agreement significantly expands biorphen commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.


    Lead Product(s): Phenylephrine Hydrochloride

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Biorphen

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Recipient: Eton Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration January 21, 2020

    Company Banner

    02

    Xellia Pharmaceuticals

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    Lead Product(s) : Phenylephrine Hydrochloride

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Recipient : Eton Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Eton Pharmaceuticals and Xellia Pharmaceuticals Announce Biorphen® (phenylephrine HCl) Co-Promoti...

    Details : Agreement significantly expands biorphen commercial footprint and provides access to institutions that prefer ready-to-use injectable formulations.

    Product Name : Biorphen

    Product Type : Miscellaneous

    Upfront Cash : Undisclosed

    January 21, 2020

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    FDF Dossiers

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    01

    Brand Name : Vancomycin Xellia

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    Regulatory Info : Approved

    Registration Country : Sweden

    Vancomycin Hydrochloride

    Xellia Pharmaceuticals

    Dosage Form : Capsule

    Brand Name : Vancomycin Xellia

    Dosage Strength : 125mg

    Packaging :

    Approval Date : 24-05-1995

    Application Number : 2.00E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    02

    Brand Name : Vancomycin Xellia

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Vancomycin Hydrochloride

    Xellia Pharmaceuticals

    Dosage Form : Solution For Injection

    Brand Name : Vancomycin Xellia

    Dosage Strength : 500mg

    Packaging :

    Approval Date : 27-09-1996

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    03

    Brand Name : Vancomycin Xellia

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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Vancomycin Hydrochloride

    Xellia Pharmaceuticals

    Dosage Form : Solution For Injection

    Brand Name : Vancomycin Xellia

    Dosage Strength : 1g

    Packaging :

    Approval Date : 27-09-1996

    Application Number : 2.00E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    04

    Brand Name : Vancomycin Xellia

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    Regulatory Info : Approved

    Registration Country : Sweden

    Vancomycin Hydrochloride

    Xellia Pharmaceuticals

    Dosage Form : Capsule

    Brand Name : Vancomycin Xellia

    Dosage Strength : 250mg

    Packaging :

    Approval Date : 23-01-1998

    Application Number : 2.00E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    05

    Brand Name : N/A

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    Regulatory Info : Generic

    Registration Country : Denmark

    Bacitracin

    Xellia Pharmaceuticals

    Dosage Form : Injection

    Brand Name :

    Dosage Strength : 50000Unit/Vial

    Packaging : 1 vial/pack, 10 vials/pack

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Denmark

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    06

    Brand Name : CASPOFUNGIN ACETATE

    Denmark
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    Regulatory Info : DISCN

    Registration Country : USA

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals

    Dosage Form : POWDER;INTRAVENOUS

    Brand Name : CASPOFUNGIN ACETATE

    Dosage Strength : 50MG/VIAL

    Packaging :

    Approval Date : 2018-07-02

    Application Number : 205923

    Regulatory Info : DISCN

    Registration Country : USA

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    07

    Brand Name : CASPOFUNGIN ACETATE

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    Regulatory Info : DISCN

    Registration Country : USA

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals

    Dosage Form : POWDER;INTRAVENOUS

    Brand Name : CASPOFUNGIN ACETATE

    Dosage Strength : 70MG/VIAL

    Packaging :

    Approval Date : 2018-07-02

    Application Number : 205923

    Regulatory Info : DISCN

    Registration Country : USA

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    08

    Brand Name : N/A

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    Regulatory Info : Generic

    Registration Country : Denmark

    Caspofungin Acetate

    Xellia Pharmaceuticals

    Dosage Form : Lyophilized Injection

    Brand Name :

    Dosage Strength : 50MG

    Packaging : 1 vial/pack

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Denmark

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    09

    Brand Name : N/A

    Denmark
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    Regulatory Info : Generic

    Registration Country : Denmark

    Caspofungin Acetate

    Xellia Pharmaceuticals

    Dosage Form : Lyophilized Injection

    Brand Name :

    Dosage Strength : 70MG

    Packaging : 1 vial/pack

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : Denmark

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    10

    Brand Name : COLISTIMETHATE SODIU...

    Denmark
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    Regulatory Info : RX

    Registration Country : USA

    COLISTIMETHATE SODIUM

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE;INJECTION

    Brand Name : COLISTIMETHATE SODIUM

    Dosage Strength : EQ 150MG BASE/VIAL

    Packaging :

    Approval Date : 2015-05-29

    Application Number : 205356

    Regulatory Info : RX

    Registration Country : USA

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    FDA Orange Book

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    01

    Brand Name : CASPOFUNGIN ACETATE

    Denmark
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    RLD : No

    TE Code :

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : CASPOFUNGIN ACETATE

    Dosage Strength : 50MG/VIAL

    Approval Date : 2018-07-02

    Application Number : 205923

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : CASPOFUNGIN ACETATE

    Denmark
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    RLD : No

    TE Code :

    CASPOFUNGIN ACETATE

    Xellia Pharmaceuticals

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : CASPOFUNGIN ACETATE

    Dosage Strength : 70MG/VIAL

    Approval Date : 2018-07-02

    Application Number : 205923

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    03

    Brand Name : COLISTIMETHATE SODIU...

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    RLD : No

    TE Code : AP

    COLISTIMETHATE SODIUM

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : COLISTIMETHATE SODIUM

    Dosage Strength : EQ 150MG BASE/VIAL

    Approval Date : 2015-05-29

    Application Number : 205356

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    04

    Brand Name : DAPTOMYCIN

    Denmark
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    RLD : No

    TE Code : AP

    DAPTOMYCIN

    Xellia Pharmaceuticals

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : DAPTOMYCIN

    Dosage Strength : 500MG/VIAL

    Approval Date : 2016-06-15

    Application Number : 206005

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    05

    Brand Name : MICAFUNGIN SODIUM

    Denmark
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    RLD : No

    TE Code : AP

    MICAFUNGIN SODIUM

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INTRAVENOUS

    Proprietary Name : MICAFUNGIN SODIUM

    Dosage Strength : EQ 50MG BASE/VIAL

    Approval Date : 2021-06-02

    Application Number : 211713

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Brand Name : MICAFUNGIN SODIUM

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    RLD : No

    TE Code : AP

    MICAFUNGIN SODIUM

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INTRAVENOUS

    Proprietary Name : MICAFUNGIN SODIUM

    Dosage Strength : EQ 100MG BASE/VIAL

    Approval Date : 2021-06-02

    Application Number : 211713

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    07

    Brand Name : POLYMYXIN B SULFATE

    Denmark
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    Booth #18A31
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    RLD : No

    TE Code : AP

    POLYMYXIN B SULFATE

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : POLYMYXIN B SULFATE

    Dosage Strength : EQ 500,000 UNITS BASE/VI...

    Approval Date : 2014-01-15

    Application Number : 202766

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    08

    Brand Name : TIGECYCLINE

    Denmark
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    RLD : No

    TE Code :

    TIGECYCLINE

    Xellia Pharmaceuticals

    Dosage Form : POWDER; INTRAVENOUS

    Proprietary Name : TIGECYCLINE

    Dosage Strength : 50MG/VIAL

    Approval Date : 2019-10-18

    Application Number : 205722

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    09

    Brand Name : TOBRAMYCIN SULFATE

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    Booth #18A31
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    RLD : No

    TE Code : AP

    TOBRAMYCIN SULFATE

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : TOBRAMYCIN SULFATE

    Dosage Strength : EQ 1.2GM BASE/VIAL

    Approval Date : 2014-09-16

    Application Number : 205685

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Brand Name : VANCOMYCIN HYDROCHLO...

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    RLD : No

    TE Code : AP

    VANCOMYCIN HYDROCHLORIDE

    Xellia Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : VANCOMYCIN HYDROCHLORIDE

    Dosage Strength : EQ 5GM BASE/VIAL

    Approval Date : 2015-12-28

    Application Number : 204125

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    KEY PRODUCTS

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    Inspections and registrations

    Check the inspections & registration from this company

    FDA

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    01

    FDA Audited

    USA
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    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-09-29

    Xellia Pharmaceuticals

    City : Bedford

    State : Ohio

    Country/Area : U.S.A

    Zip : 44146

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2023-09-29

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    02

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-12-15

    Xellia Pharmaceuticals

    City : Bedford

    State : Ohio

    Country/Area : U.S.A

    Zip : 44146

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-12-15

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    03

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-02-07

    Xellia Pharmaceuticals

    City : Bedford

    State : Ohio

    Country/Area : U.S.A

    Zip : 44146

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2022-02-07

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    04

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-10-28

    Xellia Pharmaceuticals

    City : Copenhagen S

    State :

    Country/Area : Denmark

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2021-10-28

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    05

    FDA Audited

    USA
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    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-31

    Xellia Pharmaceuticals

    City : Bedford

    State : Ohio

    Country/Area : U.S.A

    Zip : 44146

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2020-01-31

    Company Banner

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    06

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-25

    Xellia Pharmaceuticals

    City : Copenhagen S

    State :

    Country/Area : Denmark

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2019-10-25

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    07

    FDA Audited

    USA
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    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-08

    Xellia Pharmaceuticals

    City : Copenhagen S

    State :

    Country/Area : Denmark

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-05-08

    Company Banner

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    08

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-04-06

    Xellia Pharmaceuticals

    City : Taizhou

    State :

    Country/Area : China

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-04-06

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    09

    FDA Audited

    USA
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    CPhI Milan
    Booth #18A31

    District Decision : No Action Indicated

    Inspection End Date : 2016-10-13

    Xellia Pharmaceuticals

    City : Bedford

    State : Ohio

    Country/Area : U.S.A

    Zip : 44146

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2016-10-13

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    10

    FDA Audited

    USA
    arrow
    CPhI Milan
    Booth #18A31

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-03-15

    Xellia Pharmaceuticals

    City : Copenhagen S

    State :

    Country/Area : Denmark

    Zip :

    District :

    Center :

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-03-15

    Company Banner

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    Contact Xellia Pharmaceuticals ApS and get a quotation

    Xellia Pharmaceuticals ApS is a supplier offers 21 products (APIs, Excipients or Intermediates).

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